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Cancer

Henlius Breaks Ground in Gastric Cancer Treatment with Groundbreaking Phase 3 Study

Strategic Insights

— 2 min read

Henlius has achieved a significant breakthrough in the treatment of gastric cancer with the success of its phase 3 clinical study, ASTRUM-006, which met its primary endpoint of Event-Free Survival (EFS) for patients treated with the company's innovative anti-PD-1 monoclonal antibody, HANSIZHUANG, in combination with chemotherapy. This marks a pivotal shift in perioperative gastric cancer care, opening a new path for consolidating surgical outcomes and reducing recurrence risk without the need for adjuvant chemotherapy.

Key Takeaways:

  • The ASTRUM-006 study demonstrated that HANSIZHUANG, in combination with chemotherapy, significantly prolonged Event-Free Survival (EFS) and achieved a more than threefold higher pathological complete response (pCR) rate compared to the control arm.
  • The combination regimen showed a favorable safety profile, with no new safety signals identified, and a significant reduction in the risk of recurrence.
  • The study's positive outcome has led to the Independent Data Monitoring Committee (IDMC) recommending an early NDA submission.
  • HANSIZHUANG has shown unique advantages in treating various solid tumors, including inducing stronger PD-1 internalization, reducing PD-1 receptor presence on T cells, and preserving CD28 signaling.
  • The ASTRUM-006 study innovatively employed a "chemotherapy-free" serplulimab monotherapy strategy in the adjuvant setting, maintaining therapeutic efficacy while effectively circumventing toxicity related to conventional chemotherapy.
  • The success of this trial marks a pivotal shift in perioperative gastric cancer care, from a conventional intensity-driven paradigm toward a more refined "high-efficacy, low-toxicity" treatment model.
  • Henlius has built a diversified product portfolio for GI cancers, including esophageal, gastric, and colorectal cancers, addressing high-unmet needs and covering various molecular subtypes and disease stages.
  • Henlius is committed to bringing a growing portfolio of high-quality therapeutic options to patients worldwide, addressing significant unmet needs across the globe.

Statistics:

  • Approximately 969,000 new cases of gastric cancer were diagnosed worldwide in 2022, according to the latest GLOBOCAN statistics.
  • The global mortality rate for gastric cancer reached 660,000 deaths in 2022, ranking it fifth in both incidence and mortality among all cancers.
  • The ASTRUM-006 study included 250 patients with early-stage gastric cancer, who were randomized to receive either HANSIZHUANG plus chemotherapy or placebo plus chemotherapy.
  • The study met its primary endpoint of EFS, with patients treated with HANSIZHUANG plus chemotherapy showing a significant improvement in EFS compared to the control arm.

Sources:

  • Shanghai Henlius Biotech, Inc. (2696.HK) press release
  • GLOBOCAN statistics
  • ASTRUM-006 study protocol
  • Scientific publications on HANSIZHUANG's mechanism of action and efficacy in various solid tumors.

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